FDA Expands Dupixent CSU Indication to Children as Young as 2 Years

Key Takeaways

• The FDA has expanded Dupixent's indication for chronic spontaneous urticaria (CSU) to include children aged 2 to 11 years.
• Dupixent is now the first and only FDA-approved biologic for CSU patients as young as 2 years old who remain symptomatic despite H1 antihistamine treatment.
• The approval expands access to biologic therapy for pediatric CSU, a population with limited treatment options when antihistamines fail.

The US Food and Drug Administration (FDA) has expanded the indication for Dupixent (dupilumab; Sanofi and Regeneron) to include pediatric patients aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. The label expansion, according to an annoucement from the namufacturer, makes Dupixent the first and only FDA-approved biologic indicated for CSU patients as young as 2 years old.

According to the updated prescribing information, Dupixent is indicated for the treatment of adult and pediatric patients aged 2 years and older with CSU who remain symptomatic despite treatment with H1 antihistamines. The drug is not indicated for the treatment of other forms of urticaria.

The expanded approval provides an additional treatment option for pediatric patients whose symptoms are inadequately controlled with standard antihistamine therapy, the manufacturer said in the announcement. 

Source

Sanofi Regeneron announcement. June 15, 2026.